T-Control® Safety for Cytostatics Management

NCT06678633 | Not Yet Recruiting

• 1 other identifier: RM-TCONTROL-2025-06
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this pilot clinical trial is to know if this study is feasable in terms of design, recruitment and interventions, as well as gather preliminary data to determine if the T-Control® catheter is safer than the conventional Foley-type catheter during intravesical therapy with oncological patients. It will also learn about the usability of T-Control®. The main questions it aims to answer are:

• Does T-Control® lower the rate of spillages occurred during intravesical treatments?
• Is T-Control® a better device in terms of usability during intravesical treatments? Researchers will compare T-Control® catheter to a conventional Foley-type catheter (Folysil® Silicone catheter, Coloplast) to see if T-Control® reduce the rate of accidental spillages. Participants will:
• Undergo intravesical therapy with the 2 devices used in the study (in two seuqencial cycles of intravesical treatment): T-Control® catheter (experimental intervention) or Folysil® silicone catheter (control intervention).
• At the end of the procedure (1-2 hours), the catheter will be removed or changed. During the first visit, patients will be catheterised with the catheter for the randomly assigned intervention, while in the subsequent visit they will be catheterised with the alternate catheter.
• Healthcare professionals involved in the procedure will take note of spillages and others adverse events occurred during the intravesical instillation.
• At the end of the study, healthcare proffesionals will evaluate the usability perceived of both devices used for intravesical treatment.

Conditions

Non-muscle-invasive Bladder Cancer

Keywords

Intravesical therapy; Inmunotherapy; Chemotherapy; Non-muscle-invasive bladder cancer; Foley catheter; Bladder instillation

Outcome Measures

Primary Outcomes (1)

• Rate of accidental spillages

  The number of spillages with cytostatics, body fluids or other non-hazardous spillages divided by the number of interventions (intravesical therapy procedures)

  Intravesical therapy procedure (1-2 hours)

Secondary Outcomes (2)

• General device-usability

  Intravesical therapy procedure (1-2 hours)

• Specific device-usability

  Intravesical therapy procedure (1-2 hours)

Study Arms (2)

T-Control®

EXPERIMENTAL

Patients will be catheterized for intravesical therapy with a new Foley-type silicone catheter with an integrated fluid-control valve into the catheter's distal end.

Device: T-Control® (experimental)

Folysil®

ACTIVE COMPARATOR

Patients will be catheterized for intravesical therapy with Folysil® Silicone catheter (Coloplast), the usual clinical practice in the participating center.

Device: Folysil® (control)

Interventions

T-Control® (experimental) DEVICE

Patients will receive intravesical therapy (1-2 hours) through T-Control®, a new Foley-type silicone catheter with an integrated fluid-control valve into the catheter's distal end, which has three positions.

T-Control®

Folysil® (control) DEVICE

Patients will receive intravesical therapy (1-2 hours) through Folysil® Silicone catheter (Coloplast), the usual clinical practice in the participating center.

Folysil®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged ≥18 years.
• Patients with bladder cancer who require intravesical treatments with chemotherapy or immunotherapy.
• Patients requiring recurrent intravesical instillations for their treatment.
• Signed consent agreement.

You may not qualify if:

• Patients with difficult catheterisation who require a urologist to perform the catheter insertion.
• Inability to read and understand Portuguese or english.

Sponsors & Collaborators

• Rethink Medical SL: lead

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Tiago Santos

  Champalimaud Clinical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Max Mòdol

CONTACT

+ 34 654 48 94 36; mmodol@rethinkmedical.es

Manuel Luque

CONTACT

+ 34 646 30 76 42; mluque@rethinkmedical.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparative, randomised, prospective and crossover pilot study with two arms

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Within one year from the completion of the clinical investigation or three months after its early termination or temporary cessation. When, for scientific reasons, would not possible to submit the clinical research report within one year after completion of the research, it will be submitted as soon as it is available.
• Access Criteria: Available from the Sponsor upon reasonable request.